Endoscopic Ultrasound Fine Needle Aspiration Device

ABSTRACT

A handle for a medical device includes a proximal segment defining a proximal lumen extending therethrough and sized and shaped to receive an endoscopic medical device therein. A medial segment is received within a distal portion of the proximal segment and has an outer diameter smaller than an inner diameter thereof. A medial lumen extends through the proximal segment and is open to the proximal lumen. A distal segment is received within a distal portion of the medial segment and defines a distal lumen extending therethrough open to the medial lumen. The distal segment has an outer diameter smaller than an inner diameter of the medial segment. The medial segment includes a first movement limiting mechanism limiting movement of an endoscopic medical device inserted therethrough along an axis of the distal lumen and a second movement limiting mechanism limiting advancement of an endoscope attached to the distal body portion.

PRIORITY CLAIM

The present application is a Continuation of pending U.S. patentapplication Ser. No. 13/226,183 filed on Sep. 6, 2011, which claimspriority to U.S. Provisional Application Ser. No. 61/380,471, entitled“Endoscopic Ultrasound Fine Needle Aspiration Device,” filed on Sep. 7,2010. The entire disclosure of the above patents/applications isexpressly incorporated herein by reference.

BACKGROUND

may be performed with Endoscopic Ultrasound Fine Needle Aspiration(“EUS-FNA”) devices to obtain cells or small samples of tissue from, forexample, the breast or liver for cytology studies, endoscopy oroncology. As understood by those skilled in the art, biopsy needlesenable the capture of samples to facilitate diagnosis and treatment.These biopsy needles are generally connected at their proximal ends tohandles including actuation mechanisms. Currently available handles aretypically formed as two or more overlapping substantially cylindricalelements with a first element attached to an endoscope and a secondlarger diameter element overlapping a proximal portion of the firstelement being used to advance the needle to a target site in a livingbody. Presently available handles and actuation mechanisms offerinsufficient ergonomics and further require that the entire handle berotated to rotate the needle attached thereto.

SUMMARY OF THE INVENTION

The present invention relates to a handle for a medical devicecomprising a proximal segment defining a proximal lumen extendinglongitudinally therethrough, the proximal lumen being sized and shapedto receive an endoscopic medical device therein and a medial segmentreceived within a distal portion of the proximal segment, the medialsegment having an outer diameter smaller than an inner diameter of theproximal segment and defining a medial lumen extending therethrough opento the proximal lumen in combination with a distal segment receivedwithin a distal portion of the medial segment and defining a distallumen extending therethrough open to the medial lumen, the distalsegment having an outer diameter smaller than an inner diameter of themedial segment, wherein the medial segment includes a first movementlimiting mechanism limiting movement of an endoscopic medical deviceinserted through the proximal, medial and distal lumens along an axis ofthe distal lumen and the medial segment includes a second movementlimiting mechanism configured to limit advancement and retraction of anendoscope attached to a distal end of the distal body portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a first perspective view of a device according to a firstembodiment of the invention;

FIG. 2 is a second perspective view of the device of FIG. 1;

FIG. 3 is a partial cross-sectional view of the device of FIG. 1;

FIG. 4 is a perspective view of the device of FIG. 1 in a firstoperative configuration; and

FIG. 5 is a perspective view of the device of FIG. 1 in a secondoperative configuration.

DETAILED DESCRIPTION

The present invention, which may be further understood with reference tothe following description and the appended drawings, relates to handlefor an apparatus for obtaining tissue samples and, more particularlyrelates to FNA devices. The handles according to the invention may beused in substantially all procedures employing FNA devices furtherincreasing the efficacy of FNA procedures by improving handling of thedevice via an ergonomic design and also by permitting rotationalmovement of the endoscope without the need to rotate the entire shaft ofthe device. Specifically, presently available devices require that theentire endoscope or the entire handle be rotated in order to affect arotation of the needle at a target site in the body. The exemplarysystem and method according to the present invention allows for aselective rotation of only a needle of an FNA device without rotatingthe entire handle, as will be described in greater detail hereinafter.

Devices and methods according to the present invention comprise an FNAdevice including an ergonomic handle controlling rotation of an FNAdevice inserted through the device, the handle being connected to anadjustment portion controlling proximal-distal movement of the FNAneedle inserted through the FNA device and through an endoscope attachedto a distal portion of the device, the endoscope being configured forinsertion into a living body in an operative configuration.Specifically, embodiments of the present invention are directed to ahandle configured to control rotation of the FNA needle insertedtherethrough while bypassing the need to rotate the entire endoscope, asis customary with presently available devices. It is noted that the useof the term distal herein refers to a direction away from a user andtoward a target tissue treatment area and the term proximal refers to adirection approaching a user of the device (e.g., a physician) with aproximal portion of the device remaining external to the patient as anendoscope attached to the distal portion is inserted into the body.

As shown in FIGS. 1-5, an FNA actuation device 100 according to anexemplary embodiment of the present invention comprises an elongatedbody having a proximal handle portion 102, a central portion 104, adistal portion 106 and an attachment portion 108 located at a distal endthereof, the attachment portion 108 permitting attachment with anendoscope or other device for insertion into a living body in anoperative configuration. In an exemplary embodiment, components of thedevice 100 may be formed of any combination of a polymer, metal or otherknown material, as known to those of skill in the art. An exemplarymaterial of the device 100 is selected so that, when attached to anendoscope, the elements are permitted to rotate without breaking orcracking, as will be described in greater detail later on. A lumen 110extends through the device 100 from a proximal end 112 to a distal end114. The lumen 110 may be substantially circular in cross-section andmay be configured to receive a needle, stylet or another medical devicetherethrough (e.g., electrodes, knives, pincers, etc.), as those skilledin the art will understand. The needle or other medical device may beconfigured to reflect ultrasound signals, such as for example, anendoscopic ultrasound (“EUS”) needle, as those skilled in the art willunderstand. It is noted, however, that other cross-sectional shapes ofthe lumen 110 are also envisioned. Inner walls of a portion of the lumen110 extending through the proximal handle portion 102 comprise radialabutments or a treated surface (not shown) to permit a frictional ormechanical engagement with an outer wall of a needle 103 to be insertedtherethrough. The needle 103 may also comprise an abutment, a recess ora treated surface to permit such an engagement. Thus, when insertedthrough the lumen 110, the needle 103 may be moved proximally anddistally relative to the proximal handle portion 102 by application of asufficient proximally or distally directed force to a proximal end ofthe needle but may be prevented from being rotated relative thereto.Rotation of the needle 103 can only be facilitated by a rotation of theproximal handle portion 102. Alternatively, as will be understood bythose skilled in the art, the shapes of any portion of the needle,stylet or other medical device and a corresponding portion the lumen 110may be keyed to one another to prevent relative rotation therebetween.The lumen 110 also extends through the central portion 104 and distalportion 106 but is not rotatably fixed thereto. That is, the lumen 110is rotatable relative to the central portion 104 and the distal portion106. Specifically, as shown in FIG. 3, the central portion 104 anddistal portion 106 comprise a telescoping internal channel 138configured with first, second and third sections 140, 142, 144configured to be retractable into one another upon retraction of one orboth of the central and distal portions 104, 106. The lumen 110 extendsthrough the telescoping internal channel 138 and is slidable relativethereto so that retraction and expansion of the telescoping internalchannel 138 does not cause proximal or distal movement of the lumen 110.Thus, proximal retraction of the distal portion 106 causes the distalportion 106 to be withdrawn into the central portion 106 and retractionof at least the third section 144 into the second section 142.Similarly, when the central portion 104 is retracted into the proximalhandle portion 102, as will be discussed in greater detail later on, theouter wall of the central portion 104 slides into a cavity 136 withinthe proximal handle portion 102. The lumen 110 is slidable relative tothe telescoping internal channel 138 so that proximal retraction of thecentral portion 104 and distal portion 106 does not proximally retractthe needle 103 but rather, permits a greater portion of the needle 103to be exposed at a distal end of the device 100, as shown in FIG. 4. Thetelescoping internal channel 138 further comprises a lip 146 formed at aproximal end thereof to permit frictional engagement of the telescopinginternal channel 138 with an abutment 148 preventing removal of thecentral portion 104 from the proximal handle portion 102. The lumen 110extends proximally from the proximal handle portion 102 by apredetermined distance and comprises an opening 118 opening into thelumen 110 to permit insertion of the needle or other devicetherethrough.

The proximal handle portion 102 may be substantially cylindrical inshape and may be formed with an outer diameter greater than that of boththe central portion 104 and the distal portion 106. It is further notedthat the proximal handle portion 102 may also be formed with anon-circular cross-sectional shape without deviating from the scope ofthe present invention. The proximal handle portion 102 may be formedwith a taper so that its diameter increases toward a central portionthereof with proximal and distal ends of the proximal handle portion 102having a smaller diameter than that of the central portion. The proximalhandle portion 102 further comprises an ergonomic groove 116 formedadjacent a distal end thereof to aid in gripping and manipulationthereof. It is noted that although only a single groove 116 is shown,the proximal handle portion 102 may be formed with any number andvariety of grooves or abutments configured to aid in ergonomic handlingwithout deviating from the scope of the present invention. The proximalhandle portion 102 may also have a soft grip coating (e.g.,thermoplastic elastomer) or another surface modification or coating toaid in handling.

The central portion 104 extends distally from the proximal handleportion 102 by a predetermined distance and also has a substantiallycircular cross-section. A diameter of the central portion 104 in thisembodiment may be approximately 13-25 mm. The central portion 104,although securely connected to the proximal handle portion 102, remainsrotatable relative thereto. That is, rotation of the proximal handleportion 102 and the lumen 110 does not result in a rotation of thecentral portion 104. In one embodiment of the invention, the proximalhandle portion 102 comprises a radial groove (not shown) formed on aninner wall of a distal rim thereof configured to rotatably engage aradial abutment formed on an outer wall of a proximal rim of the centralportion 104. Alternatively, any connection may be forged between theproximal handle portion 102 and the central portion 104 withoutdeviating from the scope of the present invention.

The central portion 104 further comprises a first mechanism 120 and asecond mechanism 122 configured to selectively limit a proximal-distalmovement of the distal portion 106 relative to the central portion 104and movement of the central portion 104 relative to the proximal handleportion 102. Specifically, the first mechanism 120 may be formed as aring 124 extending around a portion of an outer surface of the centralportion 104. The ring 124 may be secured to the central portion 104 andmay be held in place by a friction fit or any other suitable attachmentmeans known in the art. In an exemplary embodiment, the ring 124 of thefirst mechanism 120 may be permanently secured to a distal end of thecentral portion 104. The ring 124 includes a pair of slots 126 extendingsubstantially perpendicular to a longitudinal axis of the centralportion 104 and having a length smaller than a circumference of the ring124. The slots 126 are configured to permit the device to be locked in adesired configuration. Specifically, a profile of an inner surface ofthe ring 124 adjacent to the outer surface of the distal portion 106 isnon-circular (e.g., elliptical) while a knob 128 of the mechanism 120includes one or more arms (not shown) which extend from a part of theknob 128 which is located between the ring 124 and the outer surface ofthe distal portion 106. The arms are sized so that, when the knob 128 isrotated to a first orientation, the arms are located within a spaceformed between a larger diameter portion of the non-circular innersurface of the ring 124 and the distal portion 106 so that the ring 124is loosely held around the distal portion 106. Rotation of the knob 128to a second orientation (e.g., by 90° relative to the first orientation)moves the arms into a smaller space between a reduced diameter portionof the non-circular inner surface of the ring 124 and the distal portion106 so that the ring 124 is pressed tightly against the distal portion106 locking the positions of the distal portion 106 and the centralportion 104.

The distal portion 106 is sized and shaped to be slidably receivedwithin the central actuating portion 104 and telescopically extendabletherefrom. When the distal portion 106 is manually moved to a desiredposition (i.e., using markings 107 formed on an outer wall thereof as aguide), the first mechanism 120 is tightened to apply a torque to thedistal portion 106 to lock a position thereof. The distal portion 106also comprises a distal opening 130 through which the distal end 114 ofthe lumen 110 exits the device 100.

The second mechanism 122 provided over the central portion 104 is formedsubstantially similarly to the first mechanism 120 but comprises a ring132 slidable along a length thereof to permit advancement of the centralportion 104 into and out of the proximal handle portion 102. Thus, thesecond mechanism 122 may be positioned over a target portion of thecentral portion 104 using markings 105 as a guide and tightened to locka position thereof. In this manner, the second mechanism 122 can bepositioned so that only a portion of the central portion 104 locatedproximally of the second mechanism 122 is retracted into the proximalhandle portion 102, as shown in FIG. 4. For example, when the window 123is positioned over the “8” marker at a distal-most position of thecentral portion 104, substantially the entire length of the centralportion 104 can be withdrawn proximally into the proximal handle portion102, as shown in FIG. 4. Similarly, when the second mechanism 122 ismoved to a proximal-most position along the central portion 104 (i.e.,so that a window 123 is positioned over a “0” marker), the centralportion 104 is prevented from being retracted into the proximal handleportion 102.

The attachment portion 108 has a greater diameter than the distalportion 106 and comprises internal threading 134 engaging a threadedouter wall of a proximal end of an endoscope (not shown). The distal end114 of the lumen 110 may be configured so that, when the attachmentportion 108 may be coupled to an endoscope, the lumen 110 aligns withand engages a working channel extending through the endoscope (notshown). Specifically, a proximal end of the endoscope (not shown) may bereceived within the attachment portion 108 and the attachment portion108 may be rotated to lockingly engage the threads of the endoscope. Thedistal portion 106 may include an extension member 148 mountedtherewithin that is sized and shaped for insertion into the workingchannel of the endoscope when the attachment portion 108 is coupled tothe endoscope. In one embodiment, only the attachment portion 108 may berotated to threadedly engage the endoscope (not shown). In anotherembodiment, the attachment portion 108 may not be rotatable relative tothe distal portion 106 so that, in order to threadedly engage theendoscope, the entire distal portion 106 must be rotated. In anotherembodiment of the invention, the attachment portion 108 may beconfigured to permit a luer lock connection with the endoscope.

In accordance with an exemplary method of the present application, anendoscope may be attached to the attachment portion 108. The central anddistal portions 104, 106 are then manipulated to a desired orientationand the first and second mechanisms 120, 122 are tightened to lock thedevice 100 in the desired configuration. That is, the distal portion 106may be extended to a length selected such that, when the needle 103 maybe inserted into the lumen 110 and through the endoscope, the needle bemovable between a first position in which a distal end of the needle maybe located within the endoscope lumen (e.g., substantially adjacent adistal end thereof) and a deployed position in which the needle projectsdistally beyond a distal end of the endoscope by a desired distance. Theneedle 103 may then be inserted through the FNA device 100 into theworking channel of the endoscope until the proximal end of the needlemay be locked in position at a proximal end of the device 100. At thispoint, the device 100 may be configured so that the needle 103 is in thefirst position with the distal tip thereof received within theendoscope. In addition, at this point, a stylet is preferably placed ina closed configuration in which it seals a distal opening of the needleas the needle is inserted through non-targeted tissue to the targettissue site. The endoscope is then guided to a target location withinthe body in a conventional manner and a physician or other userdetermines (e.g., under visual observation via the endoscope) whether atissue penetrating distal tip of the needle 103 is in a desiredorientation relative to target tissue to be sampled. If not, thephysician may rotate the proximal handle portion 102 by a desired anglewith the rotation being translated only to the lumen 110 and the needle103 located therein while the central portion 104, distal portion 106and the entire length of the endoscope remain substantially unaffectedby the rotation. The physician freely rotates the needle 103 by anydesired angle until the desired orientation is achieved. The needle 103may then be moved distally out of the endoscope to extend distallytherefrom by the desired distance under the guidance of an imagingdevice, as those skilled in the art will understand. At this point thestylet is also moved to a tissue receiving configuration in which thedistal opening of the needle 103 is open to receive tissue. It isfurther noted that the needle 103 may subsequently be rotated at anypoint during the target procedure as deemed necessary by the physician.

The present invention has been described with reference to specificexemplary embodiments. Those skilled in the art will understand thatvarious modifications and changes may be made to the embodiments. Thespecifications are, therefore, to be regarded in an illustrative ratherthan a restrictive sense.

1-22. (canceled)
 23. A telescoping handle for a medical device,comprising: a proximal segment defining a proximal lumen extendinglongitudinally therethrough, the proximal lumen being sized and shapedto receive an endoscopic medical device therein, the proximal segmentincluding a coupler for coupling the endoscopic medical device theretoso that the endoscopic medical device moves and rotates with theproximal segment; a medial segment received within a distal portion ofthe proximal segment, the medial segment having an outer diametersmaller than an outer diameter of the proximal segment and defining amedial lumen extending therethrough open to the proximal lumen; and adistal segment received within a distal portion of the medial segmentand defining a distal lumen extending therethrough open to the mediallumen, the distal segment having an outer diameter smaller than an outerdiameter of the medial segment, wherein the medial segment istelescopically movable into and out of the proximal segment and thedistal segment is telescopically movable into and out of the medialsegment, the medial and distal lumens being sized and shaped so that theendoscopic medical device is slidable and rotatable relative to themedial and distal segments.
 24. The telescopic handle of claim 23,further comprising a first movement limiting mechanism limiting movementof the medial segment into the proximal segment, the first movementlimiting mechanism being configured to frictionally engage an outer wallof the medial segment.
 25. The telescoping handle of claim 24, furthercomprising a second movement limiting mechanism configured to lock aposition of the distal segment relative to the medial segment.
 26. Thetelescoping handle of claim 25, wherein the second movement limitingmechanism is slidably positioned over a target portion of the medialsegment so that only a portion of the medial segment located proximallythereof is retractable into the proximal segment.
 27. The telescopinghandle of claim 24, wherein the first movement limiting mechanism locksa position of the distal segment relative to the medial segment.
 28. Thetelescoping handle of claim 23, wherein the endoscopic medical device isa needle.
 29. The telescoping handle of claim 23, wherein the distalsegment includes an attachment sized and shaped to engage acorresponding attachment at a proximal end of an endoscope to which thehandle is to be mounted.
 30. The telescoping handle of claim 23, whereinthe distal segment engages an endoscope via a luer lock.
 31. Atelescoping handle for a medical device, comprising: a proximal segmentdefining a proximal lumen extending longitudinally therethrough, theproximal lumen being sized and shaped to receive an endoscopic medicaldevice therein, the proximal segment including a coupler for couplingthe endoscopic medical device thereto so that the endoscopic medicaldevice moves and rotates with the proximal segment; a medial segmentreceived within a distal portion of the proximal segment, the medialsegment having an outer diameter smaller than an inner diameter of theproximal segment and defining a medial lumen extending therethrough opento the proximal lumen; a distal segment received within a distal portionof the medial segment and defining a distal lumen extending therethroughopen to the medial lumen, the distal segment having an outer diametersmaller than an inner diameter of the medial segment; and a telescopinginternal channel extending through the medial and distal segments, thetelescoping channel including first, second and third sectionsconfigured to be movable relative to one another upon retraction orexpansion of at least one of the medial and distal segments, wherein theproximal, medial and distal lumens are movable relative to the first,second and third sections.
 32. The telescoping handle of claim 31,wherein the medial segment is telescopically movable into and out of theproximal segment and wherein the distal segment is telescopicallymovable into and out of the medial segment.
 33. The telescoping handleof claim 31, wherein the third section is telescopically movable intoand out of the second section and wherein the second section istelescopically movable into and out of the first section.
 34. Thetelescoping handle of claim 31, wherein proximal retraction of thedistal segment into the medial segment causes retraction of the thirdsection into the second section.
 35. The telescoping handle of claim 31,wherein proximal retraction of the medial segment into proximal segmentcauses retraction of the second section into the first section.
 36. Thetelescoping handle of claim 31, wherein the third section has an outerdiameter smaller than an inner diameter of the second section.
 37. Thetelescoping handle of claim 31, wherein the second section has an outerdiameter smaller than an inner diameter of the first section.
 38. Thetelescopic handle of claim 31, further comprising a first movementlimiting mechanism limiting movement of the medial segment into theproximal segment, the first movement limiting mechanism being configuredto frictionally engage an outer wall of the medial segment.
 39. Thetelescoping handle of claim 38, further comprising a second movementlimiting mechanism configured to lock a position of the distal segmentrelative to the medial segment.
 40. The telescoping handle of claim 31,wherein the distal segment includes an attachment sized and shaped toengage a corresponding attachment at a proximal end of an endoscope towhich the handle is to be mounted.
 41. The telescoping handle of claim39, wherein the second movement limiting mechanism is slidablypositioned over a target portion of the medial segment so that only aportion of the medial segment located proximally thereof is retractableinto the proximal segment.
 42. The telescoping handle of claim 38,wherein the first movement limiting mechanism locks a position of thedistal segment relative to the medial segment.